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Product Overview

Indication

RABAVERT is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups.

Important Safety Information For Rabavert

For preexposure administration, RABAVERT is contraindicated for persons who have had a severe allergic reaction (eg, anaphylaxis) after a previous dose of RABAVERT, or to any component of RABAVERT, including bovine gelatin, chicken protein, egg protein, neomycin, chlortetracycline, and amphotericin B

There is no contraindication to postexposure prophylaxis with RABAVERT, including pregnancy, considering the almost invariably fatal outcome of rabies

During postexposure prophylaxis with RABAVERT, proceed with caution in patients who experienced a serious adverse reaction or have the potential for a severe allergic reaction, unless an alternative product is available. A patient’s risk of acquiring rabies must be carefully considered before discontinuing vaccination

Anaphylaxis, encephalitis including death, meningitis, neuroparalytic events such as encephalitis, transient paralysis, Guillain-Barré syndrome, myelitis, and retrobulbar neuritis; and multiple sclerosis have been reported to be temporally associated with the use of RABAVERT

RABAVERT must not be used subcutaneously, intradermally or intravascularly. Intravascular injection of RABAVERT may result in systemic reactions, including shock

Active immunization to RABAVERT may be impaired if Human Rabies Immune Globulin (HRIG) is administered at more than the recommended dose

In clinical trials with RABAVERT, the most common adverse reactions were injection site reactions (injection site erythema, induration, and pain); flu-like symptoms (asthenia, fatigue, fever, headache, myalgia, and malaise); arthralgia; dizziness; lymphadenopathy; nausea; and rash

Immunocompromised persons may have a diminished immune response to RABAVERT

References

Important Safety Information

For preexposure administration, RABAVERT is contraindicated for persons who have had a severe allergic reaction (eg, anaphylaxis) after a previous dose of RABAVERT, or to any component of RABAVERT, including bovine gelatin, chicken protein, egg protein, neomycin, chlortetracycline, and amphotericin B

There is no contraindication to postexposure prophylaxis with RABAVERT, including pregnancy, considering the almost invariably fatal outcome of rabies

During postexposure prophylaxis with RABAVERT, proceed with caution in patients who experienced a serious adverse reaction or have the potential for a severe allergic reaction, unless an alternative product is available. A patient’s risk of acquiring rabies must be carefully considered before discontinuing vaccination

Anaphylaxis, encephalitis including death, meningitis, neuroparalytic events such as encephalitis, transient paralysis, Guillain-Barré syndrome, myelitis, and retrobulbar neuritis; and multiple sclerosis have been reported to be temporally associated with the use of RABAVERT

RABAVERT must not be used subcutaneously, intradermally or intravascularly. Intravascular injection of RABAVERT may result in systemic reactions, including shock

Active immunization to RABAVERT may be impaired if Human Rabies Immune Globulin (HRIG) is administered at more than the recommended dose

In clinical trials with RABAVERT, the most common adverse reactions were injection site reactions (injection site erythema, induration, and pain); flu-like symptoms (asthenia, fatigue, fever, headache, myalgia, and malaise); arthralgia; dizziness; lymphadenopathy; nausea; and rash

Immunocompromised persons may have a diminished immune response to RABAVERT

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You are encouraged to report vaccine adverse events to the US Department of Health and Human Services. Visit www.vaers.hhs.gov to file a report, or call 1-800-822-7967